Monday, January 31, 2011

According to the United States Surgeon General, a single puff on a cigarette is enough to kill you. In her media interviews and press materials accompanying the release of the 2010 Surgeon General's report on smoking, Dr. Regina Benjamin made it a point of communicating to the public that a single puff of cigarette is all that it takes to trigger a heart attack.

This scientific "fact" was disseminated widely throughout the media, with headlines such as:

It is tautologically true that one puff of a cigarette can trigger a heart attack, but only in an individual who has heart disease so severe that he or she is just one puff away from a heart attack.

However, the Surgeon General was not particularly careful to qualify her statement to refer only to people with severe, pre-existing coronary artery disease. Thus, the statement was misleading and I believe, intentionally so.

I have already pointed out that Surgeon General's office lied blatantly to the American public by claiming that even brief exposure to secondhand smoke can cause cardiovascular disease and that inhaling even the smallest amount of tobacco smoke causes cancer.

But even the tautologically correct assertion that one puff of a cigarette can trigger a heart attack (in someone who is already a puff away from a heart attack) is, I believe, a damaging statement that does more public health harm than good.

Why? For two reasons.

First, I believe that such a statement undermines the public's appreciation of the important dose-response relationship between cigarette smoke exposure and disease. By making people believe that a puff of cigarette smoke is enough to kill them, the Surgeon General has removed much of the incentive for people to quit smoking. Why quit if you have already smoked for many years? If only a puff is required to kill you, then aren't you already a goner? What would be the point of quitting?

There is even less rationale for quitting among people who are around smokers. They are going to continue to inhale a puff or two of tobacco smoke, no doubt, and since that is enough to kill them, why bother worrying about their own active smoking?

Similarly, there is little reason for people to reduce their exposure to secondhand smoke. Almost everyone is going to occasionally inhale a puff or two of secondhand smoke. If that's enough to kill you, then why go through all the trouble of limiting your exposure?

In other words, what the Surgeon General has done is to decimate the public's appreciation that there exists a dose-response relationship between the amount of cigarette smoke exposure and the magnitude of disease risk. Unfortunately, it is the understanding that such a relationship exists that forms the basis of the rationale for someone quitting smoking or reducing their exposure to secondhand smoke.

The Surgeon General would have us believe that there is a threshold relationship between smoke exposure and disease risk, by which once you reach the threshold (one puff), you are already at a high risk of dropping dead from a heart attack. Beyond that, there seems to be little reason to worry about limiting your exposure. After all, you've already reached that all-important threshold.

Second, I believe that the Surgeon General's hyperbole threatens to undermine the credibility not only of her own office but also of public health and anti-smoking groups in general. When the public comes to realize that we are exaggerating the truth - by claiming that a single puff is enough to trigger a heart attack - they are not going to merely dismiss that isolated claim, but they will likely dismiss a host of other claims about the hazards of tobacco smoke, including ones that are true. The public is going to throw the baby out with the bath water, so to speak. It is the Boy Who Cried Wolf revisited.

The tactic of trying to scare people into believing that cigarette smoke is so toxic that just a single puff can kill them is not going to work in the first place. It is based on a blind adherence to the Health Belief Model, which posits that the reason why people are smoking is because they are simply not aware enough of the dangers of smoking. This assumption is heavily flawed, especially in 2011. Educating people about the hazards of cigarette smoking is hardly going to influence smoking uptake and cessation. People understand that it is bad for them. The reason they are not quitting in greater numbers has little to do with their understanding of cigarette's hazards, and everything to do with their inability to successfully counter the addiction to smoking, which is an exceedingly strong one. But the Surgeon General's office is doing nothing to actually help smokers quit.

Quite to the contrary. Ironically, the Department of Health and Human Services is doing everything it can to take effective options away from smokers to help them quit smoking. The Department's threatened ban on electronic cigarettes is a perfect example. If the Department truly believes that even a single puff on a cigarette could kill a smoker, then why would it want to ban a product which has already proven effective in helping thousands of ex-smokers quit smoking?

Unfortunately, the Department of Health and Human Services has made it clear that it would prefer smokers to continue to risk their lives by puffing on cigarettes than by switching to non-tobacco electronic cigarettes which could greatly reduce their risk of disease. And the Department would rather that ex-smokers who have already quit smoking (via use of electronic cigarettes) return to smoking, rather than maintaining themselves tobacco-free by the use of electronic cigarettes.

Apparently, then, even the Department of Health and Human Services itself does not believe its own hyperbole. If cigarette smoking were so bad that even one more puff is likely to be enough to kill many people, the Department would certainly not want to risk ex-smokers going back to cigarette smoking by taking electronic cigarettes off the market. But that very Department has seized multiple shipments of electronic cigarettes, not allowing them to enter the United States.

Cigarette smokers may be the ones puffing away, but the federal government is truly blowing smoke.

Thursday, January 27, 2011

Late last year, a federal judge invalidated New York City's ordinance which would have required the display of graphic, anti-smoking posters anywhere cigarettes are sold. The law was struck down because it violates the preemption clause in the Federal Cigarette Labeling and Advertising Act (FCLAA), which preempts state and local regulation of the advertising and promotion of cigarettes.

The Campaign for Tobacco-Free Kids has responded with a press release arguing that the federal judge is "wrong on the law" because the proposed law regulates the sale of cigarettes, not their advertising or promotion.

According to the press release, entitled "Federal Court Is Wrong on the Law in Striking Down New York City's Requirement for Tobacco Health Warning Signs in Stores,": "We believe that a federal judge was wrong on the law in striking down New York City's requirement that all businesses selling tobacco products post tobacco health warning signs. New York City acted lawfully to more effectively inform consumers about the health risks of tobacco use, and we urge the City to appeal. The judge ruled today that New York City's requirement is preempted by the Federal Cigarette Labeling and Advertising Act, which restricts the authority of states to regulate tobacco advertising and promotion. However, this ruling fails to recognize that New York City established the signage requirement as part of its regulation of the sale — not the advertising or promotion — of tobacco products, which is permitted by federal law. The new federal law enacted in June 2009 that grants the U.S. Food and Drug Administration authority over tobacco products explicitly protects the rights of states and localities to regulate the terms and conditions of tobacco sales. Contrary to today's ruling, New York City's regulation does not restrict the advertising or promotion of tobacco products."

The Rest of the Story

The Federal Cigarette Labeling and Advertising Act (FCLAA) states that: "No requirement or prohibition based on smoking and health shall be imposed under State law with respect to the advertising or promotion of any cigarettes the packages of which are labeled in conformity with the provisions of this chapter." (15 U.S.C. §1334)

The key phrase here that needs to be interpreted in light of New York City's proposed law is "with respect to."

The Campaign for Tobacco-Free Kids would have us construe "with respect to" in the most narrow possible way. The Campaign is arguing that the requirement for graphic anti-smoking posters is merely a restriction on the sale of cigarettes and does not affect the promotion of cigarettes in any substantial way that would invoke the preemption clause. The judge, however, found that such a construction of the term "with respect to" is too narrow.

Let me explain why I think the Campaign for Tobacco-Free Kids is the one who is wrong on the law and why I think that any restriction which substantially impacts the promotion of cigarettes, even if primarily intended as a restriction on cigarette sales, runs afoul of the "with respect to" meaning and therefore must be viewed as being preempted by federal law.

The clear intention of the graphic, anti-smoking posters is not simply the provision of scientific information or facts. One look at the intended images will convince anyone that the purpose of these posters is to discourage the purchase of cigarettes. In other words, this is all about requiring an anti-promotional display. It is intended to counter the promotion of cigarettes, or more accurately, to require cigarette retailers to counter their own promotion of cigarettes. There is no question that these required posters undermine the promotion of cigarettes by the store.

Thus, at its core, this regulation is not about regulating the sale of cigarettes. It is about regulating the promotion of cigarettes to the public.

Suppose that a city decided to require the display, at point of sale of cigarettes, of a six-foot poster with the text of the Surgeon General's warnings. Based on the Campaign's interpretation of the law, such a requirement would not be preempted because it is regulating the sale of cigarettes, not the advertising or labeling of these products. But such a provision would clearly be preempted by FCLAA because it is essentially requiring huge warning labels to be displayed at the point of sale. Only the federal government has the authority to regulate cigarette warning labels.

My point is that the mere fact that a regulation is intended to control the conditions under which cigarettes can be sold does not mean that the regulation is not being imposed with respect to the advertising and promotion of cigarettes. One must look more broadly at the overall impact of the restriction. If that restriction has a substantial and direct effect on the promotion of cigarettes, then it runs afoul of the preemption provision and is not permitted under federal law.

In this case, the proposed law clearly imposes a requirement regarding the promotion of cigarettes in retail stores. The law must therefore be interpreted as imposing a regulation with respect to the promotion of cigarettes. Such a regulation is preempted by FCLAA.

The city of New York has appealed the District Court judge's decision. Based on my analysis, I do not expect that appeal to ultimately be successful.

Regardless of the legality of the proposed law, I question the public health rationale for the law and the motivation behind it. If tobacco products are so unsuitable for public consumption that New York City must require stores to actively discourage customers from buying their own products, then New York City needs to simply prohibit stores from selling that product. Clearly, it is not the public's health that is of paramount importance here - it is preserving cigarette sales in the city.

Thus, this law does the exact opposite of what its anti-smoking supporters say it does: it puts economic profits above public health.

Wednesday, January 26, 2011

According to an article in the Bangor Daily News, a Maine state Senator is introducing legislation that would deny state-funded medical treatment for smokers. The bill would prevent Maine residents from receiving MaineCare (i.e., state Medicaid) benefits for medical treatment if they smoke.

According to the article: "Sen. Thomas Saviello said Friday he decided to introduce a bill to keep people receiving MaineCare — the state’s Medicaid program — from receiving benefits at the suggestion of a constituent who also works in a rural health care clinic. Saviello did not identify the woman but said she’s expected to testify in favor of his bill. He said she’s troubled when she sees MaineCare patients who have respiratory problems and smoke heavily, because taxpayers are subsidizing treatment for illnesses that could be avoided. Saviello said he’s not sure how much money could be saved by not having to treat smoking-related illnesses, but “I suspect it could be pretty significant.”"

The Rest of the Story

Believe me when I say this is not a road that we want to go down.

If we are going to deny medical care for smokers, then what about denying coverage for people who eat a poor diet, who don't exercise, who sit around watching television all day, who are overweight, who don't control their blood pressure, who don't adequately control their blood sugar, who use tanning salons, who have unsafe sex, who expose themselves heavily to secondhand smoke, and who drive without seat belts?

The beauty of the entire medical system in the United States is specifically that we do not make moral judgments about people's character in making decisions about whether to provide health care to them. Once we undermine that principle by allowing medical treatment decisions to be made based on the moral perspectives of one group or another, then all holes are barred and medical treatment becomes a religious establishment rather than a right.

Hopefully, Senator Saviello will realize that his proposal is based on discrimination and bigotry and will withdraw the bill before it sees the light of day.

It will be particularly interesting to see whether any of the anti-smoking groups in Maine will come out publicly and denounce this legislation, as they should do immediately.

Tuesday, January 25, 2011

According to an article in the Wall Street Journal, the D.C. Circuit Court of Appeals has denied a request by the FDA to re-hear, as a full court, a three-judge panel's decision in favor of the electronic cigarette industry. In that decision, the Appeals Court ruled that the FDA cannot regulate electronic cigarettes as a drug-device combination under the Food, Drug, and Cosmetic Act, but must instead regulate these products as tobacco products under the Tobacco Act.

A three judge panel of the D.C. Circuit Court of Appeals previously upheld a lower court's injunction against the FDA seizing shipments of NJOY electronic cigarettes under its Food, Drug, and Cosmetic Act regulatory power. The FDA appealed that decision, asking the full Appeals court to re-hear the issue. The Appeals Court has denied that request, meaning that if the FDA wants to appeal further, it must ask the U.S. Supreme Court to accept the case.

Thus, the original Appeals Court decision remains in effect, and at the present time, the FDA does not have the authority to regulate electronic cigarettes as drug delivery devices, but must instead regulate them as tobacco products.

3. Issue a formal rule-making on electronic cigarettes and hope that the Courts will give the Agency deference in its definition of statute.

It is very unlikely that the FDA will choose option #1, since it seems determined to deny vapers the potentially life-saving benefits of electronic cigarettes and seems to have no understanding of the benefits of harm reduction as a public health strategy.

The FDA may choose option #2, but I think it is very unlikely that the Supreme Court would take on the case at this early stage, given that the FDA has never issued any formal rulemaking on the regulation of electronic cigarettes. I think the Supreme Court would likely wait until there is a formal rulemaking on the issue before it accepts the case.

This leaves, as a most likely outcome, option #3. However, the FDA may be reluctant to do this because it could mean taking electronic cigarettes off the market and the Agency will face quite a fight if it takes this approach.

I suppose a fourth option is simply a continuation of the status quo, where the FDA regulates the marketing claims of certain electronic cigarette companies but leaves the overall market intact. From the perspective of public health, this might actually be the best outcome, at least in the short-term.

Monday, January 24, 2011

Members of the Health Committee of the New York State Assembly have a unique opportunity to save thousands of lives tomorrow when they decide whether to allow ex-smokers to remain ex-smokers by continuing to keep themselves off tobacco cigarettes with the use of electronic cigarettes.

To be very clear, passage of Assembly Bill A01468 would force thousands of ex-smokers in New York State to return to cigarette smoking by taking electronic cigarettes off the market in the state. In addition, it would prevent current smokers who want to quit from successfully quitting smoking using the most effective method currently available - vaping - thus causing immense damage to the public's health.

The bill's justification claims that electronic cigarettes contain diethylene glycol - an ingredient in anti-freeze - and carcinogens and therefore must be removed from the market because there is no evidence that they are any safer than regular cigarettes. However, this justification is factually inaccurate on both counts.

First, although diethylene glycol was detected more than 18 months ago in one cartridge of one brand of electronic cigarettes, there is no evidence that it is present in any of the more than 100 other brands of electronic cigarettes on the market. Multiple companies have had their products tested for diethylene glycol and none of the samples have turned up positive. It appears that the presence of diethylene glycol was an isolated anomaly caused by one company's errant use of a non-pharmaceutical grade of propylene glycol. Readers should note that pharmaceutical grade propylene glycol does not contain any appreciable quantities of diethylene glycol.

Second, the bill's justification ignores the fact that the levels of carcinogens found in electronic cigarettes were only trace levels - comparable to those present in nicotine patches and nicotine gum. In fact, the relevant finding from the FDA's testing was that the level of tobacco-specific nitrosamines in electronic cigarettes was more than 1000 times lower than that present in Marlboro, the most commonly smoked cigarette in New York State. Thus, there is no scientific doubt that switching from tobacco cigarettes to electronic cigarettes will substantially reduce a smoker's risk of developing cancer.

Why would the New York State Assembly want to take away from both current smokers and ex-smokers the choice to use a product that is demonstrably much safer than cigarettes and which also appears to be far more effective than nicotine replacement therapy in reducing both the craving and desire to smoke?

The majority of smokers who have switched to electronic cigarettes report an immediate and dramatic improvement in their health. If this bill passes, these largely ex-smokers will be forced to return to cigarette smoking and these health gains will be decimated.

There are few public policies that, if enacted, will almost certainly result in an increase in morbidity and mortality. Assembly Bill A01468 is, unfortunately, one of them.

It is certainly reasonable to prohibit the sale of electronic cigarettes to minors. But New York Assembly members have a unique opportunity to save lives on Tuesday by voting to delete section 2 of the bill, which bans the sale of electronic cigarettes to adults, and retain section 1, which merely prohibits the sale of this product to minors.

The Rest of the Story

A new study I co-authored which was published online ahead of print last month in the Journal of Public Health Policy was the first to comprehensively review the scientific evidence about the safety and effectiveness of electronic cigarettes (see: Cahn Z, Siegel M. Electronic cigarettes as a harm reduction strategy for tobacco control: A step forward or a repeat of past mistakes? Journal of Public Health Policy; 9 December 2010; doi:10.1057/jphp.2010.41).

After reviewing 16 laboratory studies of the constituents of electronic cigarettes, we conclude that electronic cigarettes are much safer than the real ones and therefore show tremendous promise in the fight against tobacco-related morbidity and mortality. Nevertheless, the FDA and several states are threatening to ban them from the market, an action that would benefit the tobacco companies at the expense of the public’s health.

The FDA and major anti-smoking groups keep saying that we don’t know anything about what is in electronic cigarettes. The truth is, we know a lot more about what is in electronic cigarettes than regular cigarettes. Our review shows that carcinogen levels in electronic cigarettes are up to 1,000 times lower than in tobacco cigarettes. No other constituents have been detected at levels that are of significant health concern. Thus, using electronic cigarettes (also called vaping) appears to be much safer than smoking. Taking these products off the market would force thousands of vapers to return to cigarette smoking. Why would the FDA and the anti-smoking groups want to take an action that is going to seriously harm the public’s health? The only ones who would be protected by a ban on e-cigarettes are the tobacco companies, as these new products represent the first real threat to their profits in decades.

Regarding the relative safety of electronic cigarettes, the study concludes that “few, if any, chemicals at levels detected in electronic cigarettes raise serious health concerns. Although the existing research does not warrant a conclusion that electronic cigarettes are safe in absolute terms and further clinical studies are needed to comprehensively assess the safety of electronic cigarettes, a preponderance of the available evidence shows them to be much safer than tobacco cigarettes and comparable in toxicity to conventional nicotine replacement products.”

The study also reviews preliminary evidence that electronic cigarettes can be effective in suppressing the urge to smoke, largely because they simulate the act of smoking a real cigarette. The fact that bothers the anti-smoking groups the most – that vaping looks like smoking – is precisely the fact which appears to make e-cigarettes an effective tool for smoking cessation.

Regarding the effectiveness of electronic cigarettes for smoking cessation, the study concludes as follows: “Although more research is needed before we will know how effective electronic cigarettes are at achieving smoking abstinence, there is now sufficient evidence to conclude that these products are at least capable of suppressing the urge to smoke.” There is also reason to believe that they offer an advantage over traditional nicotine delivery devices, the study argues, because smoking-related stimuli alone have been found capable of suppressing tobacco abstinence symptoms for long periods of time.

The article concludes: "The evidence reviewed in this article suggests that electronic cigarettes are a much safer alternative to tobacco cigarettes. They are likely to improve upon the efficacy of traditional pharmacotherapy for smoking cessation." While more research is needed, the article concludes that electronic cigarettes show promise as a harm reduction strategy and that removing them from the market would substantially harm the public’s health.

Friday, January 21, 2011

In what is surely the height of hypocrisy and what must become the new example for defining hypocrisy, the Bacchus Network -- a non-profit organization that promotes college-based health education in the areas of tobacco and alcohol -- is demanding that colleges reject tobacco company funding and sponsorship while itself accepting (and hiding) its own funding from an alcohol company.

The Bacchus Network offers a certification program by which universities can apply for a Silver, Gold, or Diamond award designation depending on the extent to which they: (1) ban the use of tobacco products on their campuses; and (2) prohibit the sponsorship of events and organizations as well as the funding of research by tobacco companies.

In order to be eligible for Gold or Diamond award consideration, a university certify the following:

1. "Tobacco industry and related company sponsorship of campus groups, events, individuals, and departments is prohibited. This includes scholarships, sponsorship of faculty positions, and recruiting for employment."

2. "Tobacco industry and related company sponsorship of athletic events and athletes is prohibited."

In order to gain Diamond award consideration, a university must also certify the following:

3. "The college/university divests all tobacco company stocks and holdings."

4. "The college/university does not accept any direct funding from tobacco companies."

This is all in addition to the requirement that colleges ban smoking on their campuses. (All tobacco use must be banned on campus for the Gold or Diamond awards.)

To apply for these awards, a university must also pay $295 to the Bacchus Network.

The Rest of the Story

Although the Bacchus Network web site makes no mention of the fact that the organization is funded by the alcohol industry, if you search its financial records, you'll see that it reported contributions from Anheuser-Busch of $120,000 in 2009 and $190,000 in 2008.

Thus, not only is the Bacchus Network heavily funded by the alcohol industry, but it is apparently hiding that funding. You have to search deep into the financial records to find out that it is heavily funded by Anheuser-Busch.

This is the classic definition of an alcohol industry front group.

To boot, the web site is obsessed with individual-level interventions that put all the responsibility for alcohol use on the college students. The entire blame for the problem is on the individual. Nowhere on the site does it discuss the role of alcohol industry marketing and in particular, the marketing of alcohol on college campuses.

This is of course no surprise, as I would certainly expect that an alcohol company contribution of $120,000 would be enough to deter any thought of actually discussing the role of alcohol marketing on alcohol use among college students.

The rest of the story, then, is that while the Bacchus Network demands that colleges not accept tobacco industry funding, the organization itself is heavily funded by an alcohol company.

It is laughable that Anheuser-Busch is paying out money like this to tell colleges that it is despicable to take tobacco money, but at the same time, it is fine to take alcohol money. Which kills more college students each year? Tobacco or alcohol. Clearly, the latter.

It is a brilliant scheme by Anheuser-Busch. By making these annual payments, the company is getting its money's worth. In return, the Bacchus Network is taking the focus off of alcohol marketing and putting it onto individual education and responsibility. It is also taking the focus off of banning alcohol use on campus and putting it on banning tobacco use on campus.

This is money very well spent for the alcohol industry.

I thought it was the height of hypocrisy when the American Legacy Foundation refused to give money to schools that took tobacco money, while nearly every penny of the Foundation's budget comes from the tobacco companies and the Foundation sought voluntary donations from the tobacco companies to fund its own work.

The Bacchus Network is challenging Legacy, however, for achieving the pinnacle of hypocrisy. This is going to be hard to beat.

Thursday, January 20, 2011

Smoke-Free Campus Policies are Hypocritical and Do Little to Promote College HealthAn article in Tuesday's Inside Higher Ed blog describes a new certification program offered by the Bacchus Network, a non-profit organization that promotes college-based health education. The program awards ratings to universities based in part on the degree to which they ban the use of tobacco products on their campuses.

According to the article: "Over the past few years, as the movement to turn campuses smoke- and tobacco-free gained momentum, many onlookers and health experts have asked: Is this the real thing? How enforceable, in 24/7, bacchanalian college life, are smoking bans? Completely so, according to the Bacchus Network, a nonprofit health education organization. Bacchus is offering a new accreditation program that promises to put an end to the doubts about which campuses have kicked the habit by offering, for a fee, to certify universities tobacco- and smoke-free."

"Colleges can be certified diamond, gold, or silver, depending on the lengths they go in order to rid their campuses and their investment portfolios of a relationship to tobacco. A diamond-rated university, for example, does not accept funding from tobacco companies or invest in them, and tobacco use is banned campuswide. The lower ratings drop the investment requirement and take a more lenient stance on campus tobacco use. A silver rating is roughly equivalent to a smoke-free campus, or one banning the use of cigarettes, cigars and other smoke-producing products. Gold and diamond indicate tobacco-free, meaning no snuff, chewing tobacco or other smokeless tobacco products." ...

"Last year Bacchus offered the tobacco certification service and, after five colleges paid the $295 application fee, awarded two colleges -- Winona State University and Oklahoma State University -- silver and gold certificates, respectively. Bacchus says this year’s program, which is taking applications now, will draw even more interest. The program is meant to combat the problem of colleges failing to make good on their tobacco policies. 'Some campuses might say that they’re tobacco-free, but they have a designated smoking area outside their athletic facilities," says Quinn-Zobeck [Bacchus's director of education and training].'"

The Rest of the Story

The Bacchus Network program is a load of hypocrisy. At the same time that the Bacchus Network is demanding that colleges ban all tobacco use on their campuses, it is not demanding that these same colleges ban all alcohol use on their campuses. However, alcohol use is a far greater hazard and causes far more morbidity, mortality, damage, and personal tragedy than someone smoking a cigarette in a parking lot or in a remote location of a campus.

If anything, banning alcohol use on a college campus is more justified from a public health perspective than banning all tobacco use. A ban on tobacco use on college campuses is purely paternalistic. It is not necessary to ban smoking everywhere on campus to protect nonsmokers from the hazards of secondhand smoke exposure. And it is not necessary to ban smokeless tobacco use to protect nonsmokers.

In contrast, the use of alcohol on college campuses causes significant adverse consequences even for nonusers. For example, date rape is common occurrence that is heavily influenced by alcohol use by the perpetrator. Drunk driving is another example.

While Oklahoma State University may have won a gold certificate for banning smoking anywhere on its campus, it certainly does not earn a gold star for preventing alcohol-related morbidity and mortality. Just four years ago, one of its students died due to excessive alcohol use. Nevertheless, the university still allows alcohol use in university apartments and suites.

Moreover, Oklahoma State is or at least was apparently home to physical abuse and assault on campus. According to this article, members of a college fraternity regularly assaulted student pledges with wooden paddles, exposing bare muscle in at least one case.

Why this hypocritical stance by the Bacchus Network?

Could the answer be ...

... that the organization, according to this article, apparently receives or at least has received funding from the alcohol industry?

Although the Bacchus Network web site makes no mention of the fact that the organization is funded by the alcohol industry, if you search its financial records, you'll see that it reported contributions from Anheuser-Busch of $120,000 in 2009 and $190,000 in 2008.

Thus, Bacchus is operating essentially as a front group for the alcohol industry. And it is doing a good job. Nowhere on the Bacchus site do I find any mention of alcohol advertising and the role it plays in the dangerous use of alcohol by college students.

In fact, Bacchus serves the industry well by taking the focus off the marketing practices of the industry and placing it on lack of education or awareness among college students. This is well worth the 120 grand that the alcohol industry is shelling out each year for this front group.

Frankly, I find it despicable that a network that purports to support college health would accept money from the alcohol companies -- which play a major role in the devastation that alcohol use causes on college campuses throughout the country.

The rest of the story is that smoke-free college campus policies are full of hypocrisy. The very same groups supporting these policies are not interested in banning alcohol use on campus, even though alcohol use causes far more damage and has severe adverse consequences for nonusers, something that is not true for smoking in most outdoor campus areas or for smokeless tobacco use.

In the case of the Bacchus Network, this hypocrisy has a ready explanation: the group acts as a front group for the alcohol industry. No wonder Bacchus is focusing on regulating something which has little public health impact. It doesn't want to go where the action really is - banning alcohol use on campus and curtailing the marketing of alcohol to college students - because it knows where its bread is buttered.

Wednesday, January 19, 2011

The Canadian Council for Tobacco Control (CCTC) has called for the tobacco industry to be required to disclose all cigarette ingredients and additives along with the constituents of cigarette smoke, according to a press release issued by the organization yesterday.

According to the press release: "A cigarette (filter, paper and tobacco) is reported to contain over 500 ingredients. Once lit, it generates more than 4,000 chemicals, 60 of which are known carcinogens. In Canada, tobacco companies are required to report ingredients to the federal Health Minister, but consumers will not find these ingredients listed on any cigarette package or cigarette manufacturer's website."

"The CCTC believes 'It is time to examine this issue and demand that governments treat the tobacco industry as they do other industries. There is no other consumer product that when used as directed would kill 50% of its consumers. Insisting on similar regulations to the pharmaceutical industry (where full disclosure of product ingredients and possible side effects is mandated) may seem like a good start, but following the lead of the chemical sector might be better' said CCTC Executive Director Bob Walsh. 'With over 4,000 chemicals generated by a lit cigarette, one has to wonder why there is not a greater reporting and consumer disclosure mechanism imposed on such a product. It is not unreasonable to suggest that the tobacco industry provide a Material Safety Data Sheet (an MSDS) for tobacco products as the chemical industry does with other harmful products" he added.'" ...

"the pharmaceutical industry is required to provide detailed information regarding side effects of the drugs it markets. A cigarette (be it a traditional cigarette, cigar, cigarillo or an e-cigarette) is also a nicotine delivery system, but one that is never tested for safety. 'It's time to level the playing field and impose on the tobacco industry the same level of accountability and regulation as other industries must face to ensure the protection of Canadians,' said Walsh."

The Rest of the Story

Perhaps I should be gratified to find out that the tobacco control movement in Canada is as misguided as it is here in the United States. What kind of mishegas is this? The disclosure of the more than 8,000 known constituents in cigarette smoke will do nothing to prevent tobacco-related disease. Moreover, it will add no new information, as the names of these chemicals have already been published and that has had no apparent effect on cigarette smoking.

The public already understands that cigarettes are dangerous; providing a list of chemical names is not going to make it easier for smokers to quit, nor is it going to prevent youth from starting to smoke.

It makes absolutely no contribution to the public's health to require the cigarette companies to disclose the components of cigarettes. Consumers will not be informed about the exact constituents in the smoke they are inhaling anyway. In fact, they will not be aware of most of the components in the smoke. Most of the chemicals in cigarette smoke are unknown. They have not yet been identified. There will remain as many as 96,000 or so chemicals in cigarette smoke about which Canadian smokers are not informed. The cigarette companies do not even know most of the constituents in tobacco smoke.

But more importantly, what possible use is it for consumers to have this information? Frankly, the information is already available. Anyone interested can just read Dr. Rodgman's and Dr. Perfetti's excellent book. The known components are beautifully and exquisitely cataloged.

But what difference does this make? How does it change anything? How does it contribute in any way to the protection of the public's health? The whole idea makes no sense.

Disturbingly, the Canadian Council for Tobacco Control argues that requiring the disclosure of cigarette ingredients will "ensure the protection of Canadians." I have news for the CCTC. The disclosure of the ingredients will not protect Canadians. All that will do is inform them about the specific chemicals that are killing them. What would protect Canadians is to decrease the rate of smoking, either by encouraging smokers to quit, preventing youth from starting to smoke, or both.

Moreover, the CCTC laments the fact that cigarettes in Canada are not tested for safety. What the heck does that mean? How can you test a product that kills thousands of people each year for safety? Haven't those tests already been conducted? Is there any doubt that cigarettes are unsafe? On what planet has the CCTC been living for the past six decades to think that cigarettes need to be tested for safety?

Apparently, in Canada as well as the United States, there is more concern about regulating tobacco products than actually doing something meaningful to prevent deaths from these products. Tobacco control groups in both countries are proposing strategies that are based on regulation for regulation's sake. In other words, these proposed policies regulate the industry without any positive impact on the public's health.

On the contrary, the discourse by these anti-smoking groups is going to have a negative impact on the public's health because it sets us back decades in terms of promoting the public's appreciation of the severe hazards of cigarette smoking. Now, people are being led to believe that cigarettes need to be tested for safety. Apparently, they may not be as bad as we think, so we need to examine the ingredients to find out.

The very idea of regulating the safety of tobacco products in the first place undermines the public's appreciation of the hazards of the product. After all, if the government regulates the safety of the product, the public is going to be led to believe that it isn't as bad as previously thought.

It's unfortunate that the United States anti-smoking groups' insane approach to the regulation of tobacco products has now been exported to Canada.

Tuesday, January 18, 2011

Acknowledged Purpose of Study is Not to Find Out Effects of Thirdhand Smoke, But to Promote Smoking Bans in the Home

While I have for some time argued that many anti-smoking researchers have reached pre-determined conclusions and that their research consists of cherry-picking findings so that they support these pre-determined conclusions, it is now the case that these researchers are readily admitting that they have no interest in seeing where the results of the research actually take them.

Today, I am revealing that an anti-smoking research group in California has admitted, in its grant application summary itself, that the purpose of the research is to generate data that will support a pre-determined conclusion that thirdhand smoke is toxic to exposed nonsmokers in order to promote smoking bans in private homes.

The application summary states: "Overall, our proposed work will be a critical step in a timely assessment of whether the THS exposure is genetically harmful to exposed nonsmokers, and the ensuing data will serve as the experimental evidence for framing and enforcing policies prohibiting smoking in homes, hotels, and cars in California and elsewhere in order to protect vulnerable people."

This work, which is being funded by the state of California under its Tobacco Related Disease Research Program, will investigate the potential genotoxic effects of exposure to thirdhand smoke by studying DNA adducts that might be formed in the laboratory from the reaction of secondhand smoke with ozone.

The Rest of the Story

The grant summary makes it clear that the researchers have already reached their conclusion, before having even initiated the "investigation." They state that the results of their work "will" serve as "the" evidence for "enforcing policies prohibiting smoking in homes."

In other words, the research itself is not needed. The investigators have come to a pre-determined conclusion and the purpose of the funded work is simply to generate findings which support this pre-determined conclusion so that these findings can be used to promote smoking bans in private homes in California communities.

We have now sunk to a new scientific low in tobacco control. Not only are researchers reaching pre-determined conclusions before actually conducting the research but they are now openly admitting it. Moreover, they are acknowledging this in their grant applications, and still receiving funding!

Why would the state of California want to spend a half million dollars of taxpayers' money to fund "research" that is unnecessary because the investigators have already reached their conclusions?After all, the researchers stated that their proposed work "will be a critical step in a timely assessment of whether the THS exposure is genetically harmful to exposed nonsmokers, and the ensuing data will serve as the experimental evidence for framing and enforcing policies prohibiting smoking in homes, hotels, and cars in California and elsewhere in order to protect vulnerable people," instead of stating that their work will assess whether THS exposure is harmful and the ensuing data will inform the debate over whether to ban smoking in the home, hotels, and cars in order to protect susceptible nonsmokers.

If the researchers already have the answers, then it is a waste of time and money to carry out the proposed research. They might as well save the half a million dollars for the taxpayers of California.

That the state of California would fund research with an acknowledged pre-determined conclusion is as bad as the fact that the investigators submitted such an application.

Friday, January 14, 2011

And Why Didn't the Authors Conclude that Secondhand Smoke Does Not Cause Asthma in Children?

It is still not clear to me how a study examining the relationship between parental smoking and blood pressure in children could conclude that there is a causal relationship between the two without controlling for (or even considering) salt intake. It is highly likely that children of parents who smoke also have a higher salt intake. And if that is true, then they are also going to have higher blood pressure. Since the magnitude of the increased systolic pressure among children of smokers was very small (only 1 mm Hg), even a small difference in salt intake between the groups could explain the observed finding.

I find it odd that a paper would conclude, based only on a single cross-sectional study, that secondhand smoke exposure increases blood pressure, especially when the study did not measure salt intake.

Furthermore, it is difficult for me to understand why no one recognized the problem with the study's assessment of asthma medication use. According to the paper, asthma medication use was ascertained in the study. However, the paper reports that out of 4236 children in the study, only 3 used asthma medication that could increase blood pressure (beta-agonists or corticosteroids). This represents a proportion of 0.07%. That just 0.07% of 5-6 year-old children in the study population use asthma medications like beta-agonists or corticosteroids is simply not believable. Did no one notice this?

Perhaps the most telling oddity with this paper is its failure to conclude that secondhand smoke is not associated with asthma in children. Since the paper found no association between parental smoking and childhood asthma, why would it not also conclude that parental smoking is not associated with childhood asthma? It appears that the paper is being very selective in its conclusions. Essentially, it is cherry-picking the findings that it likes, and ignoring the findings that it doesn't like.

Now I do not believe that this research supports the conclusion that there is no association between secondhand smoke and asthma. I think a more likely explanation is that the study did not properly assess asthma in this population. This would explain the near impossible finding that only 0.07% of the children took asthma medication.

But since the study authors apparently are confident in their assessment of asthma and asthma medication use (so much so that they are willing to conclude that parental smoking causes increased blood pressure), then why aren't they willing to also conclude that parental smoking is not associated with childhood asthma?

The Rest of the Story

The rest of the story is that I detect a significant bias here. It really appears that the researchers are aiming to link secondhand smoke with increased blood pressure, rather than to objectively examine the relationship. They are cherry-picking from their findings and only giving credence to the finding that goes along with their apparently pre-determined conclusion, and not to the finding that goes against what they apparently want to find.

This bias has become increasingly apparent over the past few years and seems particularly problematic with studies on the effects of secondhand smoke.

Thursday, January 13, 2011

A new study published online in the January issue of the journal Circulation concludes that secondhand smoke exposure causes increased blood pressure in children ages 5-6 years (see: Simonetti GD, et al. Determinants of blood pressure in preschool children: The role of parental smoking. Circulation 2011; 1213:292-298).

The study was a cross-sectional examination of 4236 children ages 5-6 years living in southwestern Germany. Researchers correlated the subjects' blood pressure with their exposure to parental smoking, controlling for a number of risk factors, including body mass index, prematurity, low birth weight, parental hypertension, parental education, and maternal smoking during pregnancy.

The results were as follows: "In addition to classic risk factors such as body mass index, prematurity, low birth weight, and parental hypertension, both systolic (+1.0 [95% confidence interval, +0.5 to +1.5] mm Hg; P=0.0001) and diastolic blood pressure (+0.5 [+0.03 to +0.9] mm Hg; P=0.03) were higher in children of smoking parents. Parental smoking independently affected systolic blood pressure (P=0.001) even after correction for other risk factors, such as body mass index, parental hypertension, or birth weight, increasing the likelihood of having a systolic blood pressure in the top 15% of the population by 21% (2% to 44%; P=0.02)."

There are two potential confounding factors which were either not considered or not adequately considered and which I believe invalidate the study conclusion.

1. The Use of Asthma Medication Which Increases Blood Pressure

One of the two most important potential confounding variables is the use of asthma medication by children. The most common type of medication - beta agonists - are well known to increase blood pressure. It is also well-recognized that asthma is more prevalent among children whose parents smoke. Thus, this is an important confounder.

Children whose parents smoke are more likely to use asthma medications that increase blood pressure. If there were no true relationship between secondhand smoke and blood pressure, one would find an increased blood pressure among children exposed to secondhand smoke simply because they are more likely to use asthma medication, which itself increases blood pressure. This is a classic example of the way in which failure to control for an important confounding variable can lead to the finding of a spurious relationship between an exposure and an outcome.

Although the study considers this potential confounder, it is clear that it does not do so adequately. According to the paper, asthma medication use was ascertained in the study. However, the paper reports that out of 4236 children in the study, only 3 used asthma medication that could increase blood pressure (beta-agonists or corticosteroids). This represents a proportion of 0.07%.

That just 0.07% of 5-6 year-old children in the study population use asthma medications like beta-agonists or corticosteroids is simply not believable. A study in the United States reported that 7.4% of 5-9 year-old children in a relatively healthy population use asthma medications that could increase blood pressure. Thus, it is quite clear that the present study did not adequately assess asthma medication use and did not adequately control for this confounding variable.

Perhaps the most telling finding of the paper is that "No difference in the prevalence of asthma or bronchitis was found for children from smoking or nonsmoking families." This is not believable, given the very strong connection between secondhand smoke exposure and asthma.

If the authors trust their own data, then why did they not conclude that secondhand smoke has no association with asthma? After all, their study findings support the conclusion that there is no connection between parental smoking and asthma in young children. Curiously, they failed to draw such a conclusion in the study, or even to mention it in the discussion section.

I don't think there is any doubt that the paper does not adequately measure asthma or the use of asthma medications and therefore, I think it is clear that the paper does not adequately control for this critical confounding factor.

2. Salt Intake

It is very well recognized that among kindergarten-aged children, salt intake is a very important influence on blood pressure. Based on a 2006 study published in the journal Hypertension, just a 42% difference in salt intake among the exposed and unexposed children could explain the entire observed difference in blood pressure in the study. The study, entitled "Importance of Salt in Determining Blood Pressure in Children," makes it very clear that salt intake has a profound effect on blood pressure in young children.

It is a reasonable hypothesis that children of parents who smoke are more likely to ingest greater quantities of salt in their diets. Since increased salt intake raises blood pressure, salt intake could easily confound the relationship between parental smoking and blood pressure. Once again, failure to consider salt intake could lead to a spurious relationship between secondhand smoke exposure and blood pressure.

This study apparently did not measure or consider salt intake as a potential confounding variable.

The rest of the story is that the conclusion of this paper is premature. While it certainly found an association between parental smoking and increased blood pressure, it is not clear the extent to which that relationship is attributable to the increased use of asthma medications in children of smokers and/or to increased salt intake in these children. Without adequate consideration of these two critical potential confounding variables, the paper cannot credibly conclude that secondhand smoke is the cause of the very small increase in systolic blood pressure observed among the children of smokers in this study.

Unfortunately, the conclusions have already been disseminated through the media and so even if the appropriate analyses are done and the findings are found to be invalid, it will be too late.

Wednesday, January 12, 2011

A national anti-smoking group has publicly claimed that electronic cigarettes are deadly.

In a communication that was apparently sent out to its constituents, Action on Smoking and Health (ASH) asserts that electronic cigarettes are deadly due to the nicotine, propylene glycol, carcinogens, and other toxins delivered to the user. ASH also implies that the electronic vapor can be deadly to non-users.

According to the communication: "Long after nonsmokers like you helped ASH ban smoking on airplanes -- first on short flights, then all domestic ones, and finally on international ones -- smoking on airplanes is back. But this time passengers are smoking e-cigarettes [e-cigs] that emit a deadly mixture of nicotine (an addictive drug which contributes to heart attacks), propylene glycol (a respiratory irritant which can cause respiratory tract infections), and a wide variety of carcinogens and toxins."

ASH also claims that vaping on airplanes leads to the formation and deposition of extremely potent cancer-causing chemicals on seats and carpeting of airplanes which exposes passengers:

"This comes at a time when new research shows that nicotine emitted by e-cigs combines with chemicals in the air to form extremely potent cancer-causing chemicals which adhere to surfaces like seats and carpeting where they linger and further expose unsuspecting passengers."

ASH further asserts that people near vapers are forced to inhale nicotine and tobacco-specific nitrosamines:

"We all fought long and hard for the right to inhale air free from tobacco smoke, but here we are again being forced to inhale nicotine and deadly carcinogenic tobacco-specific nitrosamines."

The Rest of the Story

ASH claims that electronic cigarettes are deadly. I challenge ASH to identify a single death caused by electronic cigarettes, either by "active vaping" or "passive vaping" (being next to someone who is vaping).

After all, deadly means that the product is killing people -- or at very least, one person.

ASH also claims that research has shown that vaping on airplanes results in the formation of carcinogens that adhere to surfaces and expose subsequent passengers. This is an outright lie. There is no such evidence. No study has ever been done which documents that vaping results in the formation of carcinogens that adhere to surfaces, and no study has ever been done which documents that vaping on airplanes results in the deposition of such carcinogens or to carcinogen exposure among passengers.

ASH's claim that people near vapers are exposed to nicotine and tobacco-specific nitrosamines is unsupported by any scientific evidence. There is no study that has ever demonstrated that "second-hand vaping" results in nicotine or carcinogen exposure.

I strongly criticize ASH for supporting a ban on vaping in public places by lying to its constituents and by grossly distorting the science. Not only is this tactic morally objectionable, but it also undermines the credibility of the entire tobacco control movement.

Coming on the heels of my revelations that a large number of other prominent, national anti-smoking organizations are lying to the public (including the FDA, Surgeon General's office, and Americans for Nonsmokers' Rights), this story makes it compellingly clear that the scientific integrity of the anti-smoking movement is imploding.

This deeply saddens me, as there was a time when we in tobacco control took our scientific integrity very seriously. Those times are apparently long gone.

Tuesday, January 11, 2011

The FDA has argued that it must seize shipments of electronic cigarettes and threaten to enforce a ban on these products because they have not been demonstrated to be effective for smoking cessation. Companies claiming that electronic cigarettes are helpful in smoking cessation have been served with warning letters instructing them to discontinue such claims or to produce the evidence for their effectiveness. According to the FDA, "all five companies claim without FDA review of relevant evidence that the products help users quit smoking cigarettes."

The Rest of the Story

This may be all well and good, but why is the same FDA which is threatening to ban electronic cigarettes because they have not been proven effective in promoting smoking cessation not also threatening to ban E-Z Quit Artificial Cigarettes, which are another smokeless product marketed with claims that they help users quit smoking? According to the E-Z Quit web site: "When you inhale through an E-Z QUIT, the cartridge releases a flavor that refreshes your mouth and occupies your taste buds. Through psychological mechanisms it "fools you" into thinking you are smoking the real thing, and as a result it helps you to quit smoking. You just inhale through this device whenever you get the next urge to smoke, and it helps carry you over each crisis."

Clearly, E-Z Quit is making the very same claim that the cited electronic cigarette companies are making: that the product will help users to quit smoking. However, I am not aware of any clinical trial evidence that E-Z Quit artificial cigarettes are effective for smoking cessation. So why should E-Z Quit be allowed to make such a claim but electronic cigarette companies not be allowed to make the claim? Especially when there is actually an abundance of anecdotal evidence that electronic cigarettes are effective, and there are several published studies which provide evidence that these products are capable of suppressing the urge to smoke. If anything, we have a lot more evidence that electronic cigarettes are effective than that E-Z Quit artificial cigarettes are effective. So why is the FDA threatening to ban the former, but not the latter?

E-Z Quit artificial cigarettes are just one example of a smokeless cigarette alternative that is being marketed for smoking cessation free of FDA interference. There are many others.

Where are the clinical trials demonstrating that Mint Snuff Pouches are effective in helping smokers quit? These products are clearly being marketed as smoking cessation aids. The title of the web page is: "Quit Smoking Cigarettes." The company claims: "Mint Snuff Pouches are the perfect alternative to cigarettes and smokeless tobacco and they freshen your breath, too! The next time you reach for a cigarette, Pop a Pouch instead." A similar product - Mint Snuff Chew - is being marketed as helping smokeless tobacco users to quit: "Mint Snuff Chew is a non-tobacco chew made of mint instead of tobacco which has helped thousands of tobacco users quit tobacco."

What I'd like to know is where is the FDA's evidence that Mint Snuff Chew is effective for quitting smokeless tobacco? Where, FDA, are the clinical trials demonstrating that Mint Snuff Pouches are effective in helping smokers quit?

The company is making direct claims that the primary purpose of the product is to help users quit smoking cigarettes or quit chewing tobacco. Where are the FDA's warning letters to the manufacturer of Mint Snuff Chew, demanding that the company carry out clinical trials to establish the effectiveness of the product in helping smokers quit?

Yet another example is Bacc-Off, which is clearly being marketed with the direct and primary purpose of quitting smokeless tobacco use. In fact, the company claims that: "If you are trying to quit the use of smokeless tobacco, but need something as a substitute, Bacc-Off is the perfect solution."

So where is the warning letter to the manufacturer of Bacc-Off, demanding to see the clinical trials which demonstrate that smokeless tobacco users who try the product are significantly more likely to quit than those who try a placebo? Where are those clinical trials?

I'm also interested in seeing the clinical trials demonstrating that Ciga-Mint helps smokers quit. The company is making unequivocal drug claims: smoking cessation claims. Yet I don't see any FDA warning letter to the Ciga-Mint company demanding to see the clinical trials of this product's effectiveness in smoking cessation.

Similarly, where are the warning letters demanding to see the clinical trial data showing that the following products, each of which is claiming effectiveness in promoting smoking cessation, have been demonstrated to be effective in helping smokers quit:

Ice Breakers Mints and Gum ("For the individual trying to quit smoking, Ice Breakers Mints and Gum provide an alternative, especially during those difficult first weeks. Pop an Ice Breaker into your mouth to deal with that cigarette desire.")

I'm not aware of any clinical trials demonstrating that these cigarette alternatives, which are being marketed as smoking deterrent drugs, are effective for smoking cessation. Yet the FDA is not taking action against these companies to ensure that the products are not marketed until they are proven to be effective for smoking cessation.

And where in the world is the FDA on Smokers' Cleanse? This product claims not only to help you quit smoking, but it makes the specific claim that it will improve "overall lung and respiratory health." If that's not a drug claim, then I don't know what is. Yet I'm aware of no clinical trials to show that Smokers' Cleanse is effective in helping people quit smoking. Nor am I aware of any FDA warning letters to the manufacturer of Smokers' Cleanse, insisting that it refrain from making smoking cessation claims in the absence of clinical trial evidence.

Don't get me wrong. I'm not arguing here that each of these smokefree cigarette alternatives or smoking cessation remedies should be taken off the market. I'm simply arguing that electronic cigarette companies should not be required to conduct clinical trials demonstrating that these devices are effective for smoking cessation while these other companies are allowed to make smoking cessation claims without such evidence. There needs to be some consistency in FDA policy towards smoking cessation products.

Monday, January 10, 2011

The Director of the FDA's Center for Tobacco Products said last week that due to the Agency's new regulations, consumers will finally know the constituents of the tobacco smoke that they are inhaling. The rules require tobacco companies to disclose any changes to the ingredients in their products. The Tobacco Act itself requires tobacco companies to provide a list to the FDA of the ingredients, additives, and known constituents in cigarette smoke.

According to an article in the New York Times: "Federal regulators on Wednesday outlined rules for the tobacco industry that for the first time require disclosure of any changes to their products, and that detail how to seek permission to market new products under the sweeping tobacco control law signed by President Obama in June 2009. “Up to now, tobacco products have been the only mass-consumed products for which users do not know what they are consuming,” Dr. Lawrence R. Deyton, director of the Center for Tobacco Products of the Food and Drug Administration, said in a conference call with reporters."

Dr. Deyton's point was further emphasized in an article in Internal Medicine News, which quoted him as stating: "The ingredients of these products have not ever been known to those people who consume them."

According to an article in the Los Angeles Times, the Campaign for Tobacco-Free Kids called this new rule one of the most important actions the FDA can take on tobacco regulation: "'This may be one of the most important actions the FDA takes on tobacco regulation,' said Matthew Myers, president of the Campaign for Tobacco-Free Kids. 'They're going to get the chemistry. They've never had that before.'"

According to the Internal Medicine Newsarticle, Dr. David Ashley - director of the FDA's Center for Tobacco Products' Office of Science - stated: "The standard we work under when looking at these products is a public health standard. That is at the center of all the decisions we are making."

The Rest of the Story

In asserting that "up to now, tobacco products have been the only mass-consumed products for which users do not know what they are consuming," the FDA Center for Tobacco Products implies that now (after implementation of the new rules and disclosure of ingredients), users will know what they are consuming.

This assertion is incorrect and is based on a misunderstanding of tobacco science.

The rest of the story is that even after the FDA rules are implemented, consumers will still largely have no idea what is in the cigarette smoke that they are inhaling. And furthermore, the rest of the story is that right now, we know just about as much as we will after the implementation of the law about the constituents of cigarette smoke.

The law will add virtually nothing to our understanding of the constituents in cigarette smoke and after its implementation, consumers will still largely have no idea what is in the cigarette smoke that they inhale.

Why? Because of these two facts that the FDA's Center for Tobacco Products has overlooked:

1. We already know about 8,400 of the chemicals in cigarette smoke, but that knowledge does nothing for our ability to make a difference in smoking-related disease. The tobacco companies' disclosures will add very little to this list that we already have.

2. While only about 8,400 of the chemicals in cigarette smoke have been identified, there are as many as 100,000 chemicals in the smoke. Thus, even after the tobacco company disclosures, we will still only have identified about 8.4% of the chemicals in cigarette smoke. Thus, consumers will still essentially have no idea what they are inhaling.

According to an authoritative textbook on the chemical components of tobacco and tobacco smoke written by two eminent R.J. Reynolds analytic chemists, consumers will never know what is in the smoke they are inhaling because there are as many as 100,000 chemicals in the smoke -- most of which have not even been identified (see: Rodgman A, Perfetti TA. The Chemical Components of Tobacco and Tobacco Smoke. Boca Raton, FL: CRC Press, 2008).

Perhaps we should all chip in and buy a copy of the book for the FDA's Center for Tobacco Products. It's only $273.38 on Amazon, and it ships free with Super Saver Shipping. If 100 readers are willing to put in two bucks each, I'll throw in the other $73.38. Only three are left in stock so we better act quickly.

In the book, Rodgman and Perfetti review and catalog over 8400 tobacco and tobacco smoke components (this is substantially more than the 4,000 chemicals number that is typically cited). According to these R.J. Reynolds scientists, cigarette smoke alone contains more than 5300 chemicals: "The number of identified components in cigarette tobacco smoke has increased almost 100-fold from the fifty definitively identified tobacco smoke components listed by Kosak to the more than 5300 components identified to date and cataloged by RJRT personnel."

Importantly, however, these R.J. Reynolds chemists note that the actual number of constituents in tobacco smoke is most likely much higher, because for every identified chemical, there are probably many more unidentified ones: "Despite the identification of over 5200 additional smoke components since the 1954 listing by Kosak, various investigators have estimated from gas chromatographic scans that for each component identified in tobacco smoke there are five to twenty components present at extremely low per cigarette yields that have not yet been identified."

In fact, Rodgman and Perfetti cite gas chromatographic evidence that the true number of constituents in tobacco and tobacco smoke is probably more than 10,000 and may even be as high as 100,000: "Gas chromatographic scans indicate there are many more, probably over ten thousand, possibly even a hundred thousand tobacco smoke components."

The most important implication of the science of tobacco smoke is that it exposes the absurdity of the FDA's tobacco regulatory approach. The best the FDA can do is to regulate the levels of a few of the 100,000 chemicals in tobacco smoke. Moreover, the overwhelming majority of the chemicals in tobacco smoke have not even been identified. So how can the FDA hope to improve the safety of the product by removing or lowering the levels of just a few of the identified components? We don't even know what the majority of the chemicals in tobacco smoke are and we have no idea what role these unidentified chemicals play in the health effects of cigarette smoking.

When you have a product with as many as 100,000 chemical constituents, regulating the levels of a select few of these constituents is simply not a reasonable, sensible, science-based approach to the problem. The Tobacco Act is not a science-based policy. It is a pure political maneuver, designed to have the appearance of being a bona fide health measure, but in reality being a complete scam that institutionalizes cigarettes, creates an FDA seal of approval for cigarettes, and protects existing cigarette products from competition from potentially safer ones.

A second important implication of this science is that it makes absolutely no contribution to the public's health to require the cigarette companies to disclose the components of cigarettes. Consumers will not be informed about the exact constituents in the smoke they are inhaling. In fact, they will not be aware of most of the components in the smoke. There will remain as many as 96,000 or so chemicals in their smoke about which they are not informed. The cigarette companies do not even know most of the constituents in tobacco smoke.

But more importantly, what possible use is it for consumers to have this information? Frankly, the information is already available. Anyone interested can just read Dr. Rodgman's and Dr. Perfetti's excellent book. The known components are beautifully and exquisitely cataloged.

But what difference does this make? How does it change anything? How does it contribute in any way to the protection of the public's health? The whole idea makes no sense.

This is what makes so comedic the Campaign for Tobacco-Free Kids' statement that this is the most important regulatory action that the FDA can take. In reality, this action is a waste of time. It does nothing to protect the public's health. All that it accomplishes is to give the public a false sense of security about the safety of cigarettes.

The ultimate absurdity is the Center for Tobacco Products' statement that "the standard we work under when looking at these products is a public health standard." What kind of crazy public health standard says that as long as you have a product that includes the same chemical mix that is already killing hundreds of thousands of Americans each year, you're fine to continue marketing and selling them? What kind of public health standard accepts 400,000 deaths per year and is designed simply to make sure that the number doesn't increase?

Clearly, I must have missed that lesson during my public health training. That must have been the day I climbed out the window and skipped class.

The FDA's regulatory approach to tobacco products is a joke. It would be funny if not for the fact that hundreds of thousands of Americans will continue to die each year from the products which this Agency is now going to officially approve for marketing and sale in the United States.

Friday, January 07, 2011

According to Americans for Nonsmokers' Rights (ANR) - a leading national smoke-free air advocacy - active smoking is no worse than secondhand smoke exposure.

In a fact sheet entitled "Secondhand Smoke: The Science," the group claims that the health effects of secondhand smoke are virtually the same as those of active smoking. According to the fact sheet, "there are virtually no health disparities between active and passive smoking."

The fact sheet also states that active smoking only causes the same amount of heart damage as 30 minutes of exposure to secondhand smoke.

The precise statements made by ANR are as follows:

1. "A June 2004 study published in the British Medical Journal reaffirmed that there are virtually no health disparities between active and passive smoking. The risks of heart disease associated with secondhand smoke are twice what were previously thought and are virtually indistinguishable from those associated with active smoking."

2. "Just thirty minutes of exposure to secondhand smoke can cause heart damage similar to that of habitual smokers."

The Rest of the Story

These false claims are damaging because they undermine decades of public education about the hazards of active smoking. They represent a lie that is every bit as false as anything the tobacco industry has fraudulently asserted in the historical annals of tobacco industry lies and deception.

The claims are particularly damaging because if believed by the public, they remove any incentive for smokers to quit. If smoking is only as bad as secondhand smoke exposure, then the hazards of active smoking are no where near as great as previously thought. Moreover, if smokers are going to be around people who smoke anyway, then there is no incentive for them to quit.

At this point, I am convinced that this statement by Americans for Nonsmokers' Rights is not a simple mistake or oversight. It is a deliberate lie. I say this because I have informed the group on multiple occasions of these factual errors and it has apparently decided not to remove, change, or even clarify these claims. I have offered specific language that would correct the claims, but those changes were apparently rejected by ANR. Thus, I can only assume that the organization has made an intentional decision to retain these factually inaccurate claims on its web site.

This is particularly sad to me because I used to be on the Executive Board of Americans for Nonsmokers' Rights. At that time, the organization was very concerned about the scientific accuracy of its statements. I wrote a number of documents that were used by the organization and helped to ensure the scientific integrity of many the claims that we made about the health effects of secondhand smoke.

But suddenly, things changed. In 1999, ANR refused to clarify a statement I made in a document on its web site in order to ensure that it would be properly interpreted. Even though the document was mine (I wrote it), ANR would not post a slight revision that corrected a statement that inadvertently was misleading. After ANR refused to post my revised document, I demanded that the organization remove the document from its web site. It refused and instead, simply took my name off. You can read the entire story here.

The explanation for ANR's refusal to honor my copyright and to post my minor correction: "ANR must put its political credibility ahead of what you consider to be your scientific credibility." The organization admitted that its political concerns were more important than the scientific truth.

I therefore resigned from the ANR Board. Sadly, it appears that the same philosophy of putting politics ahead of scientific honesty continues in the organization to this day.

As I have said before, this is quite unfortunate because the simple truth would be enough to promote policies to protect workers and the public from the hazards of secondhand smoke exposure. I have testified in more than 100 cities in favor of 100% smokefree workplace laws and have been successful in the overwhelming majority of them, simply by speaking the truth about the health effects of secondhand smoke and by providing accurate scientific information. There simply is no need to lie in order to promote smoke-free policies.

Thursday, January 06, 2011

Here is a question for you. The Food and Drug Administration (FDA) announced yesterday that it will "protect the health of all Americans." Which of the following actions did the FDA take?

A. Eliminate the nicotine in cigarettes so that they are much less addictive.B. Regulate the carcinogens in cigarettes so that they are much less carcinogenic.C. Implement a multi-million dollar advertising campaign to discourage tobacco use so that smoking initiation rates become much lower.D. Reach an agreement with electronic cigarette manufacturers on a regulatory system for these products that will result in a substantial number of smokers quitting via use of these innovative and much safer products.E. Vow to protect the health of all Americans by making cigarettes safer...no...I mean, by agreeing not to allow cigarettes that are more hazardous than the ones that are already killing more than 400,000 Americans each year.

The answer is...

... E. Vow to protect the health of all Americans by making cigarettes safer...no...I mean, by agreeing not to allow cigarettes that are more hazardous than the ones that are already killing more than 400,000 Americans each year.

If this is the best they can do, they might want to consider quitting their day jobs.

The action announced by the FDA yesterday was the release of industry guidance indicating that all changes to products on the market will be reviewed to make sure that these products do not become "more dangerous."

If you think that's funny, the funniest part of this story is actually that this "praiseworthy" action of the FDA was touted by the Campaign for Tobacco-Free Kids as being a huge victory for the public's health.

Do you mean to tell me that this is the great public health victory that all the anti-smoking groups, politicians, and federal agencies like the FDA and Department of Health and Human Services have been raving about? We can all breathe a lot easier - and live a lot longer - because the deadly cigarettes on the market will not be made any more deadly.

This is truly cause to celebrate in the streets. How about a flash mob on the Capitol steps to show our appreciation for this courageous and game-changing public health initiative?

It's difficult to believe, but FDA Commissioner Margaret Hamburg actually stated that this complete non-action is going to protect the health of all Americans. She said: "This piece of the Tobacco Control Act protects the health of all Americans."

This is what we pay the FDA for? To make sure that the deadly tobacco products that are killing hundreds of thousands of Americans each year don't suddenly become more deadly than they already are?

And is this why we contribute money to the Campaign for Tobacco-Free Kids? To make sure that the death toll from tobacco rises no higher than 400,000 and that its health care costs remain at $100 billion per year?

Can you imagine if the FDA announced that it was going to "protect the health of all Americans" by making sure that new non-steroidal anti-inflammatory drugs don't cause more heart attacks than Vioxx?

Would we all be praising the FDA and touting a great public health victory if the Agency issued a guidance for pharmaceutical companies indicating that no changes to pain medications would be allowed if those changes resulted in more severe heart rhythm abnormalities than were caused by Darvon?

Would health groups be applauding the FDA for announcing that in evaluating cold medicines in the future, its standard of review would be whether or not the proposed drug causes more hemorrhagic strokes, or more severe hemorrhagic strokes, than phenylpropanolamine?

Would the FDA have the gall to issue a self-congratulatory press release boasting that it will require all new Parkinson's disease medications to show that they are no more likely to cause leaky heart valves than Permax?

This is a great day for the children of America. Sure, they will continue to die in the future at a rate of 400,000 a year. But it is a great day for rejoicing in public health because it won't be any higher than that!

Wednesday, January 05, 2011

Shortly before the New Year, Dr. Greg Connolly - a member of the FDA's Tobacco Products Scientific Advisory Committee (TPSAC) - resigned from the panel. Yesterday, Dr. Joshua Sharfstein - the Deputy Commissioner of the FDA - resigned, according to an article in the Wall Street Journal.

It is unlikely that this sudden gap in the FDA will be filled by individuals who are stronger advocates for drug safety and for tobacco control than Drs. Connolly and Sharfstein. Both are strong public health advocates who fought tooth and nails against deceptive or fraudulent practices of the tobacco and pharmaceutical industries.

According to the article: "The Food and Drug Administration's No. 2 official is leaving the agency after a busy 21-month tenure that included clashes with drug and device makers over tougher regulation. Deputy Commissioner Joshua Sharfstein, 41 years old, is taking the top public-health job for the state of Maryland, a spokesman for Maryland's governor said, with an announcement scheduled for Wednesday. The FDA is losing a regulator who has pushed for a greater emphasis on drug safety. For example, he helped bring about an unusual review of the diabetes drug Avandia last year that resulted in much tighter curbs on its use. The departure could have an effect on the FDA's coming release of new guidelines on medical-device approvals. Any significant restrictions will likely cause a backlash in the device industry, which has allies among Republican House leaders." ...

"After arriving in late March 2009, when he briefly served as acting commissioner, Dr. Sharfstein took on the FDA's device division, where a device for knee surgery had been cleared in late 2008 over the repeated objections of a half-dozen FDA scientists and managers. His review, prompted by articles in The Wall Street Journal in 2009, led to the FDA's announcement that it planned to revoke the approval of the knee device. The FDA also said it would likely toughen guidelines for an abbreviated device-approval process that is popular with the industry."

"Under Dr. Hamburg and Dr. Sharfstein, the agency is issuing more warning letters over manufacturing and marketing violations, while largely stopping the practice of letting companies spend months negotiating the content of these letters, according to industry lobbyists in Washington. Another change that has alarmed the industry is the focus by the FDA on punishing individual executives and corporate lawyers, not just companies, over alleged wrongdoing. In November, a former lawyer for GlaxoSmithKline PLC was indicted in a Justice Department and FDA investigation into Glaxo marketing practices. The company has said it was cooperating with the government. The lawyer has pleaded not guilty."

"Dr. Sharfstein's review of Avandia, the troubled diabetes drug, opened a rift with the longtime head of the FDA's drug division, Janet Woodcock, who had defended the drug as a useful option for patients. The sides came to a truce in September, with restrictions that all but ended new prescriptions of the drug while allowing patients still on it to continue to use it."

The Rest of the Story

It is not clear why Dr. Connolly and Dr. Sharfstein have resigned from their respective positions, as neither has spoken publicly about the reasons for their resignations. However, for individuals who are as dedicated and principled as Dr. Connolly and Dr. Sharfstein, it is common for these types of resignations to occur as a result of frustration due to political interference with science-based decision-making.

The state of Maryland is lucky to have a state health commissioner with as much expertise, dedication, and character as Dr. Sharfstein. The FDA's loss will certainly be the state of Maryland's gain.

In the mean time, one must wonder what is going on at the Agency if it is unable to retain individuals of the kind of experience, expertise, and character as Drs. Connolly and Sharfstein. The FDA has already come under scrutiny because of the perception of widespread political interference in agency decision-making and because of failures in its ability to handle even its existing responsibilities. I can only imagine the circumstances that would have led to the departure of these two fine individuals.

Tuesday, January 04, 2011

Despite being informed about several factual inaccuracies in its fact sheet entitled "Secondhand Smoke: The Science," Americans for Nonsmokers' Rights (ANR) has apparently decided not to change or clarify the false health claims made in the fact sheet.

The false claims made in the fact sheet and the reasons why these claims are untrue are as follows:

The Lies: (1) "there are virtually no health disparities between active and passive smoking."; (2) "The risks of heart disease associated with secondhand smoke are twice what were previously thought and are virtually indistinguishable from those associated with active smoking."; (3) "Just thirty minutes of exposure to secondhand smoke can cause heart damage similar to that of habitual smokers."

The Rest of the Story: ANR's claim that there are virtually no health disparities between active and passive smoking is a lie. If ANR were being truthful in claiming that passive smoking has virtually the same level of health effects as active smoking, then there would be tens of thousands more deaths from secondhand smoke than we currently observe. How can ANR can claim that there are virtually no health disparities between active and passive smoking? That implies that active smoking is virtually no more dangerous than exposure to secondhand smoke. We know this is not true, because there is a dose-response relationship between tobacco smoke exposure and lung cancer. The relative risk of lung cancer among active smokers is about 17, while the relative risk of lung cancer among passive smokers is about 1.3. Even if we restrict ourselves to the risk of heart disease, the scientific evidence simply doesn't support the conclusion that the risk of heart disease is "virtually" the same for active and passive smokers. If ANR were to inform an active smoker that his risk of heart disease was no different than that of a passive smoker, it would essentially represent malpractice, because unless this smoker is an extremely light smoker, the information is undeniably false.

The statement that brief exposure to secondhand smoke causes heart damage in nonsmokers similar to that observed in active smokers is also a lie. Nonsmokers exposed briefly to secondhand smoke do not suffer heart damage similar to that of habitual smokers. In fact, they do not suffer heart damage at all. Brief tobacco smoke exposure does not cause heart damage. What is does cause is endothelial damage (reversible vascular injury to the cells that line the coronary arteries). Heart damage refers to actual damage to the heart muscle, such as one sustains after myocardial ischemia or a heart attack. Believe me, the subjects in the Otsuka experiment did not suffer heart damage. If they did, they could sue the university for causing this damage. The IRB would never approved the study if it was even thought that the tobacco smoke exposure might cause heart damage. ANR is disseminating a lie that distorts the truth and makes brief tobacco smoke exposure sound much worse that it actually is.

Despite being informed of these false scientific claims (presuming that my email was received) on October 28 and November 29 of last year, as of today, the fact sheet remains unchanged. I take this as an indication that ANR has decided not to change or clarify these claims.

The Rest of the Story

I just don't understand why ANR would not want to fix these statements so that they are true rather than false. In fact, they only require minor editing to correct them.

Here is how each of the three statements could be slightly altered in order to make them true instead of false:

1 - ACCURATE VERSION: "The effects of secondhand smoke exposure on endothelial function are virtually identical to those of active smoking."

2 - FALSE VERSION: "The risks of heart disease associated with secondhand smoke are twice what were previously thought and are virtually indistinguishable from those associated with active smoking."

2 - ACCURATE VERSION: "The effects of tobacco smoke exposure on cardiovascular disease are nonlinear; as a result, the risk of heart disease associated with chronic exposure to secondhand smoke may actually approach that of very light, active smoking."

3 - FALSE VERSION: "Just thirty minutes of exposure to secondhand smoke can cause heart damage similar to that of habitual smokers."

3 - ACCURATE VERSION: "Just thirty minutes of exposure to secondhand smoke can cause endothelial dysfunction similar to that observed in active smokers."

If ANR were to correct these claims so that they are accurate, what exactly would be the loss? What possible reason is there not to make these corrections? The statements are still very powerful and convey the high level of health risk associated with secondhand smoke exposure. In fact, I think they explain more accurately exactly why secondhand smoke is so strongly linked to heart disease. The statements are no less powerful in providing a rationale for regulating tobacco smoke exposure in workplaces and public places. The only real difference is that these statements are accurate, while ANR's claims are inaccurate.

About Me

Dr. Siegel is a Professor in the Department of Community Health Sciences, Boston University School of Public Health. He has 32 years of experience in the field of tobacco control. He previously spent two years working at the Office on Smoking and Health at CDC, where he conducted research on secondhand smoke and cigarette advertising. He has published nearly 70 papers related to tobacco. He testified in the landmark Engle lawsuit against the tobacco companies, which resulted in an unprecedented $145 billion verdict against the industry. He teaches social and behavioral sciences, mass communication and public health, and public health advocacy in the Masters of Public Health program.